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Heart Warning Added to Bextra Label

Bextra Not for Use in Patients Undergoing Heart Bypass Surgery

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Dec. 9, 2004 -- The FDA announced today new warnings for the arthritis drug Bextra.

The new warning states that Bextra should not be used in patients undergoing heart bypass surgery. In October, Bextra's manufacturer, Pfizer, announced results of a study showing an increase in heart problems in patients having heart bypass surgery. In that study, patients were receiving Bextra for treatment of pain following surgery.

The FDA is also strengthening warnings regarding a potentially fatal skin reaction from Bextra.

Bextra is a Cox-2 inhibitor that is used for arthritis and other painful conditions. Another similar drug, Vioxx, was removed from the market in September due to an increase in heart attacks and stroke in patients taking the drug for at least 18 months.

The FDA is planning on holding a panel discussion early in 2005 to discuss appropriate uses for Bextra and other anti-inflammatory drugs.

Heart Risks

A recently completed study conducted by Pfizer included more than 1,500 patients treated after heart bypass surgery. The study showed increases in heart attacks, strokes, and blood clots in the legs and lungs in patients treated with Bextra. In the study, about 1% of patients suffered one of these effects after taking Bextra. This was compared with 0.5% of patients taking a placebo.

Serious Skin Reactions

The FDA is also strengthening warnings regarding potentially serious skin reactions from Bextra.

The new warning says that patients taking Bextra have reported serious, potentially fatal skin reactions. These skin reactions are most likely to occur in the first two weeks of treatment but can occur any time during therapy. In a few cases, these reactions have resulted in death.

The FDA is telling doctors that Bextra should be discontinued at the first appearance of a skin rash, sores on the inside of the mouth, or any other sign of allergic reactions. The new warning also states that Bextra contains sulfa, and patients with a history of allergic reactions to sulfa may be at a greater risk of skin reactions.

As of November 2004, the FDA had received reports of 87 cases in the U.S. of severe skin reactions in association with Bextra. Twenty of the 87 cases involved patients with a known allergy to sulfa. Of these 87 cases, four died.

Other Cox-2 inhibitors, such as Celebrex, and older anti-inflammatory drugs, such as naproxen and ibuprofen, also have a risk for these rare, serious skin reactions, but the reported rate of these serious side effects appears to be greater for Bextra.